Agiolax granules 400 g pack with measuring spoon

Agiolax granules 400 g pack with measuring spoon is a natural laxative indicated for the treatment of occasional constipation in adults and adolescents over 12 years of age. Its unique formulation combines plantain seeds (Ispaghula) and senna , two ingredients known for their effectiveness in promoting intestinal movement and stimulating peristalsis in a gentle and natural way. The granules, practical to dose thanks to the measuring spoon included in the pack, act as a natural remedy for constipation, helping to regulate the intestine without irritating the intestinal mucosa.

The presence of plantain seeds guarantees a bulking action that softens the stool, while senna stimulates intestinal motility, promoting physiological and effortless evacuation. Agiolax granules are ideal for those looking for a delicate intestinal granule , suitable for daily use in case of occasional constipation. The product is easy to take and can be integrated into the evening routine for an optimal effect. Thanks to its composition, it represents an effective and safe solution for those who want an intestinal medicine that acts naturally and respects the intestinal balance.

ACTIVE INGREDIENTS

Active ingredients contained in Agiolax granules 400 g pack with measuring spoon - What is the active ingredient in Agiolax granules 400 g pack with measuring spoon?

100 g of granules contain Active ingredients: - Ispaghula seed 52 g - Ispaghula cuticle 2.2 g - Senna fruit 6.74 - 13.15 g equivalent to 300 mg of hydroxyanthracene derivatives calculated as sennoside B Excipients with known effect: sucrose For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Agiolax granules 400 g pack with measuring spoon - What does Agiolax granules 400 g pack with measuring spoon contain?

Talc, gum arabic, cumin essence, sage essence, mint essence, liquid paraffin, solid paraffin, E 172, sucrose.

DIRECTIONS

Therapeutic indications Agiolax granules 400 g pack with measuring spoon - Why is Agiolax granules 400 g pack with measuring spoon used? What is it for?

Short-term treatment of occasional constipation in adults and adolescents over 12 years of age.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Agiolax granules 400 g pack with measuring spoon - When should Agiolax granules 400 g pack with measuring spoon not be used?

• hypersensitivity to the active substances or to any of the excipients listed in section 6.1 • sudden irregularity of bowel function persisting for more than 2 weeks • acute or unknown abdominal pain • nausea or vomiting • intestinal obstruction • oesophageal or gastrointestinal stenosis • rectal bleeding of unknown origin • failure to pass stool following the use of laxatives • severe state of dehydration • dysphagia, hiatus hernia or conditions involving the risk of regurgitation • colonic atony • megacolon • faecal impaction • children under 12 years of age • pregnancy and breast-feeding (see section 4.6) • Crohn's disease, ulcerative colitis and appendicitis

DOSAGE

Quantity and method of taking Agiolax granules 400 g pack with measuring spoon - How do you take Agiolax granules 400 g pack with measuring spoon?

Dosage The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is recommended to initially use the minimum doses provided. When necessary, the dose can be increased. Do not exceed the maximum recommended daily dose. Adults and adolescents over 12 years: The recommended dose is 5 g or 10 g of granules (corresponding to 1 - 2 measuring spoons) once a day. 1-2 sachets of 5 g once a day. Do not exceed the maximum recommended daily dose. Children Agiolax is contraindicated in children under 12 years of age (see section 4.3). A single dose of 5 g of granules contains: 2.6 g of Ispaghula seed 0.11 g of Ispaghula husk 0.34 - 0.66 g of Senna fruit Method of administration For oral use. The granules should not be chewed or dissolved, but should be placed on the tongue and swallowed, standing upright, drinking a large glass of water. Agiolax should always be taken with liquids. Without sufficient liquids, the product may swell and obstruct the pharynx or esophagus, creating the risk of suffocation (see section 4.4). It can be taken independently of meals. Take preferably in the evening, one hour before bedtime. Use the graduated measuring spoon supplied with the package. Duration of treatment Laxatives should be used as infrequently as possible and should not be used for more than 7 days. If after 3 days no improvement is observed or abdominal pain or bowel irregularity occurs, re-evaluate the clinical picture. Prolonged use should be decided after adequate clinical evaluation.

CONSERVATION

Storage Agiolax granules 400 g pack with measuring spoon - How do you store Agiolax granules 400 g pack with measuring spoon?

100 g, 250 g, 400 g container: Store below 25°C Sachets: Store below 30°C. Keep in the original package in order to protect from moisture.

WARNINGS

Warnings Agiolax granules 400 g pack with measuring spoon - About Agiolax granules 400 g pack with measuring spoon it is important to know that:

Warnings Abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhoea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In the most serious cases, dehydration or hypokalaemia may occur, which can cause cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with certain medicinal products (see section 4.5). Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). During treatment with Agiolax, it is necessary to ingest a large quantity of water (6-8 glasses per day) to prevent the onset of intestinal obstruction. Agiolax should be used only if a therapeutic effect cannot be obtained by modifying the diet or administering bulk laxatives. The concomitant use of laxatives with thyroid hormones may require adjustment of the dose of thyroid hormones. Given the risk of gastrointestinal obstruction, Agiolax should not be used together with medicinal products known to inhibit peristaltic movement (see section 4.5). After oral intake or contact with the skin, Agiolax may cause hypersensitivity reactions (see section 4.8). Abdominal pain, spasms and diarrhoea may occur, especially in case of pre-existing irritable bowel syndrome (see section 4.8). These symptoms may also occur following overdose; in this circumstance it is necessary to reduce the dose (see section 4.9). Important information about some of the excipients Agiolax contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

INTERACTIONS

Interactions Agiolax granules 400 g pack with measuring spoon - Which medicines or foods can modify the effect of Agiolax granules 400 g pack with measuring spoon?

Hypokalaemia (resulting from long-term abuse of laxatives) potentiates the effects of cardiac glycosides and interacts with antiarrhythmic drugs, drugs that induce the reversal of sinus rhythm (e.g. quinidine) and drugs that induce QT prolongation. Concomitant use of diuretics, corticosteroids and liquorice root may increase electrolyte imbalance. Laxatives may reduce the residence time in the intestine, and therefore the absorption, of other drugs administered concomitantly by mouth (e.g. vitamin B12, coumarin derivatives, lithium and carbamazepine). Concomitant administration of antidiabetics may increase the risk of hypoglycaemia. Avoid taking laxatives and other drugs at the same time: leave an interval of at least 2 hours before or after taking the laxative and another medicine. Agiolax may enhance the risk of opioid-induced obstruction due to reduced peristalsis (see section 4.4).

SIDE EFFECTS

Like all medicines, Agiolax granules 400 g pack with measuring spoon can cause side effects - What are the side effects of Agiolax granules 400 g pack with measuring spoon?

Adverse reactions are reported according to MedDRA system organ class. Adverse reactions are listed using the MedDRA frequency convention: very common (≥1/10); common (≥1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare ≥ 1/10,000, < 1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Adverse reactions are reported in decreasing order of seriousness.

MedDRA System Organ Classification	Rare (≥ 1/10,000, ≤ 1/1,000)	Very rare (≤1/10,000)	Not known
Gastrointestinal disorders	Abdominal colic*, Flatulence, Abdominal distension, Gastrointestinal obstruction, Fecaloma	Obstruction of the esophagus	Nausea, Vomiting, Diarrhea
Kidney and urinary disorders	Chromaturia***		Albuminuria**, Hematuria**
Immune system disorders			Hypersensitivity reactions, Anaphylactic reactions, Rash, Pruritus

*more frequently in case of severe constipation or irritable bowel syndrome; ** from prolonged use; *** this coloration is due to the presence of senna components in the urine and is not clinically significant. Furthermore, colon melanosis has been reported which recedes after discontinuation of the medicinal product. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Agiolax granules 400 g pack with measuring spoon - What are the risks of Agiolax granules 400 g pack with measuring spoon in case of overdose?

Excessive doses may cause abdominal spasms, abdominal pain, flatulence, intestinal obstruction and severe diarrhea, in which case treatment should be discontinued and the resulting fluid and electrolyte losses should be replaced. Prolonged use of high doses of anthraquinone-containing drugs may cause toxic hepatitis.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Agiolax granules 400 g pack with measuring spoon.

Pregnancy Use during pregnancy is contraindicated due to the known genotoxicity of anthraquinones contained in senna (see section 4.3). Breastfeeding Small amounts of active metabolites of anthraquinones, such as rhein are excreted in breast milk, therefore the use of Agiolax during breastfeeding is contraindicated (see section 4.3). Fertility No fertility studies have been performed.

DRIVING AND USE OF MACHINERY

Take Agiolax granules 400 g pack with measuring spoon before driving or using machines - Does Agiolax granules 400 g pack with measuring spoon affect driving or using machines?

Agiolax does not alter the ability to drive vehicles or use machines.